PrEP HIV drugs: fight for limited NHS funds takes unedifying turn

The fight in the courts over who should pay for drugs to protect against HIV infection has taken an unedifying turn. There have been allegations that gay men will become more promiscuous if NHS England pays for the pills as a result of the high court ruling and that children with cystic fibrosis will be deprived of a drug that could help them breathe.

The issues are as emotive as they could be, just as they have always been over the battles for access to new cancer drugs that might give women with young children a few more weeks of life. But the problem is exactly the same one. Hard decisions have to be taken as long as the NHS has a limited pot of money to spend.

The high court action was brought by the National Aids Trust because NHS England was trying to hand the bill for pre-exposure prophylaxis (PrEP) drugs – taken in successful trials by gay men to protect themselves against HIV infection during sex – to the local authorities, who were given responsibility for public health. The local authorities, also responsible for tackling obesity, alcohol and smoking, said they did not have the cash.

NHS England lost. Although it intends to appeal, it has set out its plans for what it will do if the appeal fails. That will involve incredibly difficult decisions. PrEP will have to come out of the specialist commissioning budget, which is £15.6bn in 2016/17. There are 146 different services competing for that pot of money, ranging, the court heard, from renal dialysis and secure in-patient mental health services, through to treatment for rare cancers and life-threatening genetic disorders – as well as a drug for children with cystic fibrosis.

NHS England has prioritised some of these services into levels 1 and 2. Those will go ahead, come what may, it said after the judgment. But decisions on levels 3 and 4 have been postponed until after the appeal. If NHS England loses, it must then decide which services to fund – and it still may not include PrEP.

Simon Stevens, the head of NHS England, flagged up the problem to the health select committee in June. “PrEP has great potential and all of us would like to see it more widely available in this country,” he said.

But Truvada, the drug used in the trials, has not yet been assessed for cost-effectiveness, although the National Institute for Health and Care Excellence (Nice) has been asked to look at it.

But, Stevens went on: “This particular drug is not yet licensed for prophylactic treatment for HIV.

“Frankly, the prices that the manufacturer is seeking to charge probably also need to take a substantial haircut to represent value.”

Truvada is a drug that has been used in treating HIV infection for years and was licensed in 2005. But in the two months since Stevens spoke, Gilead, the manufacturer, has received approval from the European Medicines Agency to change and extend its licence for PrEP use. That will be rubber-stamped by the European commission in six to eight weeks. When that happens, it can charge what it thinks the market will bear and nobody will be able to make a cheaper copy until the new patent expires – and that could be a decade or two.

The cost at the moment is about £400 a month, or £4,800 a year for each person treated. The NAT and other Aids campaigners rightly argue that is low compared with the estimated average of £360,000 over a lifetime for treating somebody with HIV. There are about 103,700 people with HIV in the UK. The numbers of gay men becoming infected in the UK hit a record high of 2,800 in 2014, which is about eight every day. NAT told the court that is accruing £2.88m in extra costs to the NHS daily. In that context, PrEP looks very cost-effective.

But for NHS England it is a case of finding the money. There are thought to be 10,000 to 15,000 people considered to be at high risk of infection because they have multiple partners and sometimes do not use condoms.

Interestingly, NHS England intends to go on the offensive. It says it will call in the manufacturers of the various drugs competing for funds – including Gilead – and ask for a “best and final” price. Just possibly some of the companies will take a cut in their profits rather than lose sales. And just maybe this will lead to the naming and shaming of drug companies – holding them responsible for the men at risk of HIV and the children who cannot breathe, rather than the NHS.

PrEP HIV drugs: fight for limited NHS funds takes unedifying turn

"Chemsex" hazards are not limited just to gay men | @guardianletters

Chemsex: Neighborhood authorities should commission London-wide open entry sexual wellness and drug companies. Photograph: Dosfotos/PYMCA /REX

Your recent post (Gay men warned on critical dangers of ‘chemsex’, 9 April) highlights the critical risk to each individual and public wellness posed by the emergence of “chemsex”. Whilst this impacts overwhelmingly on the gay community and in distinct (though not only) in London, it is crucial to recognise other groups are also impacted by the developing use of these medicines (as well as “legal highs”), such as younger folks, college students and clubbers, as mentioned in yet another of your posts on the same day (Steroid users pose new HIV infection risk, authorities warn).

The robust association with substantial-threat sexual behaviour and sexual unwell-wellness, including the transmission of HIV and hepatitis C, has highlighted the require for better hyperlinks in between sexual well being and drug companies. Even so, really handful of integrated services exist, and these that do are now only accessible to neighborhood residents due to latest adjustments in NHS commissioning. We are concerned that this will severely restrict accessibility to care for these vulnerable groups from all areas of London. We phone on neighborhood authorities in London to jointly commission completely integrated, London-broad, open access, LGBT-distinct (but open to all) sexual overall health and drug companies, and for other nearby authorities to do likewise in regions the place equivalent problems have been identified.
Dr Ann Sullivan Consultant, Chelsea and Westminster Hospital NHS Foundation Trust, Dr Jan Clarke President, British Association for Sexual Well being and HIV, Dr David Asboe Chair, British HIV Association, Yusef Azad Director of policy and campaigns, Nationwide Aids Trusts, Dr Emma Devitt Advisor, Chelsea and Westminster Hospital NHS Foundation Trust, Dr Christopher Hilton Consultant liaison psychiatrist, West London Psychological Well being Believe in/Imperial College London, Dr Alan McOwan Lead clinician, 56 Dean Street, Dr Michael Rayment Advisor, Homerton University Hospital,, London Dr Fiona Burns Consultant, Royal Cost-free London NHS Basis Believe in, Dr Christopher Scott Advisor, Chelsea and Westminster Hospital NHS Foundation Believe in, Dr Alan Winston Reader in HIV medicine, Imperial University London

"Chemsex" hazards are not limited just to gay men | @guardianletters

Angela Merkel ready to offer Britain limited EU opt-outs

Angela Merkel is believed to be inclined to grant ‘limited opt-outs’ to David Cameron’s government. Photograph: Sean Gallup/Getty Photos

Angela Merkel is prepared to grant David Cameron specific assurances in a revised EU treaty to ensure that the interests of Britain and other non-euro members are protected in the European single market place.

In a sign of the lengths the German chancellor is prepared to go to to make sure Britain stays in the EU, authoritative sources in Berlin say Merkel is also ready to grant “constrained opt-outs” to Britain and to ensure that EU regulations are enforced in a far more flexible way.

1 senior figure in Berlin has raised the prospect of providing the NHS an opt-out from the functioning time directive – a contentious measure criticised by Eurosceptics – which gives workers a series of rights.

The thinking amid senior figures in Berlin has emerged on the eve of a go to to Britain by Merkel on Thursday in which the German chancellor will meet the Queen, address a joint session of parliament and hold separate meetings with the leaders of the 3 main political events.

Downing Street believes Merkel will be the pivotal EU figure if Cameron wins the 2015 basic election and embarks on a renegotiation of Britain’s EU membership terms just before a referendum by the end of 2017.

The Foreign Workplace is advising Downing Street not to shed sight of the truth that Britain will need to have the agreement of all other 27 EU leaders if it is to attain a favourable revision of the Lisbon treaty. One source said: “There is perhaps also much optimism emanating from No ten. We have to be a quite difficult-headed about this and bear in thoughts that the bedrock of the EU is the Franco-German partnership. There is only so far the Germans will go. We should be generating a significantly greater energy with the French.”

Senior figures in Berlin have outlined a series of concessions they would be prepared to grant Britain to help the prime minister win a referendum campaign. They say Merkel believes new governance arrangements for the eurozone will have to be launched in “targeted” treaty change. This would go past a simple “simplified revision procedure” but would fall brief of a full “inter-governmental conference” modify that would take at least five many years.

The prime minister regards treaty change as vital because it would hand Britain, which would have a veto, a likelihood to table its demands.

One particular senior Berlin official said: “Cameron’s assumption that there will be treaty modify is almost definitely appropriate. I am assured that a number of legal routes exist to get by way of adjustments in treaties, based on political constellations. We are not speaking about rewriting the treaties but making targeted changes or submitting an addendum. It may lengthen beyond a limited treaty revision under the simplified revision process (on the model of the treaty facilitating the establishment of the European Stability Mechanism) but Germany does not want a basic treaty revision.”

The considering in Berlin is outlined in a paper drawn up by the City of London Corporation and the Policy Network thinktank. Officials advised the authors of the paper that Berlin is ready to countenance offering:

• Assurances that Britain and the nine other EU members outside the euro will not be outvoted when guidelines are drawn up for the single market place, which covers all 28 members. Cameron has voiced fears that the non-euro members could fall victim to “caucusing” by the 18 members of the euro because the guidelines of the single marketplace are made the decision by “experienced majority voting” in which no member state has a veto. One particular senior official is quoted as saying: “Germany is sympathetic to British demand for assurances of non-discrimination in single industry provided eurozone integration. Even so this can not extend to a reversion to unanimity above fiscal services regulation. […] In negotiations on a new treaty, I could see the inclusion of a new clause to safeguard the United kingdom against discrimination as a euro out.”

• Limited opt-outs for Britain, even though these would fall quick of repatriation of powers. A single idea is the NHS exemption from the EU’s operating time directive. British workers can opt out of the 48-hour doing work week but other demands in the directive, this kind of as holidays and rest breaks, are mandatory.

• The implementation of EU regulations in a much less intrusive and prescriptive way. This would apply across the EU and would be designed to meet British considerations that EU regulations fail to get account of the considerations of businesses.

A senior Berlin government adviser is quoted in the paper as saying: “There is also a lot life style regulation coming out of Brussels. It is critical that the EU seems at its core organization in instances of crisis and does no matter what it can to advertise financial growth. Germany might be ready to countenance the abrogation of some secondary legislation.”

1 senior Whitehall figure mentioned that Merkel was keen to aid Cameron but there were lines she would not cross. The source said: “Angela Merkel wants Britain to keep in the EU and desires to do what she is able to do to assist with that. But she is not simply going to throw over key German interests and that contains the stability of the euro.

“Merkel and Cameron have a shared vision about the existential economic challenge dealing with Europe as a total – the want for competitiveness, to see the emerging economies as an chance as well as a challenge. She regards Cameron as one particular of the few European leaders who will get that. It is correct she needs us in since of where the stability of the financial argument lies and also due to the fact a British exit would damage the EU in the eyes of the world beyond.”

But Sir Menzies Campbell, the former leader of the Liberal Democrats, mentioned the Tories were incorrect to feel Merkel would be ready to grant significant concessions. Campbell stated: “Any individual who believes that Merkel, who is following all the leader of a coalition, is going to come to London with the sort of agenda that would satisfy the most rabid anti-Europeans in the Conservative celebration has acquired yet another think coming. Germany and France have been the engine room of the EU, typically resentful of the truth that Britain appeared from time to time to be disconnected. Why need to Merkel offer some kind of unique romantic relationship for the United kingdom underneath a Tory celebration which embarrassed her by leaving the European People’s party [in the European parliament] as quickly as the 2010 election was in excess of?”

David Cameron and Angela Merkel have forged this kind of a robust bond in recent years that aides like to debate the precise moment when they clicked.

There was the time when they went for a walk minus aides, accompanied just by their security detail, up Coombe Hill close to the prime minister’s nation residence in Chequers in the Chilterns in the autumn of 2010.

Then there was the box set of Midsomer Murders DVDs Cameron handed to the German chancellor at the end of the Chequers weekend soon after they had spent hrs watching Merkel’s favourite detective drama.

Others say it is crucial not to fail to remember the prime minister’s go to, accompanied by his wife and children, to the German equivalent of Chequers at Schloss Meseberg in April last year. Merkel is explained to have been especially attentive to the Cameron kids.

The strength of their bond exhibits that the two leaders have come a long way given that Cameron announced throughout the Tory leadership contest in 2005 that he would take his celebration out of the primary centre proper grouping in the European parliament.

Even prior to his appointment as prime minister in 2010 Cameron worked tough to rebuild relations with Merkel who now regards him as a “naughty nephew”, 1 No ten source advised the Mail on Sunday.

Cameron calculated that he would be unable to obtain considerably in Europe without having the assistance of the leader of the EU’s greatest nation and economic climate. Merkel was encouraged by Cameron’s fairly constructive approach towards the EU after he became prime minister.

But their relations suffered a blow at the finish of 2011 when Cameron vetoed a fiscal compact for the eurozone, forcing the eurozone members to agree a separate treaty outdoors the architecture of the EU. The fallout from that row, which prompted fears in the German chancellery that Britain could leave the EU, ended up strengthening their partnership. Merkel advised Cameron in the run up to his main speech on Britain and the EU in January last 12 months to argue in favour of reform across the EU. She said that would be the best way of developing a consensus across the EU.

The German chancellor is established to see Britain continue to be in the EU. But the Foreign Workplace has warned Cameron to bear in thoughts that any German chancellor will also place Berlin’s relationship with France very first. Nicholas Watt

Angela Merkel ready to offer Britain limited EU opt-outs